Spots Global Cancer Trial Database for Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
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Trial Identification
Brief Title: Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
Official Title: A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)
Study ID: NCT00135876
Interventions
Study Description
Brief Summary: In patients with malignant glioma, to determine the efficacy of prophylaxis with LMWH (dalteparin) compared to placebo, both commenced beyond the immediate postoperative period, for the prevention of VTE.
Detailed Description: Patients are randomized 1:1 to receive dalteparin 5,000 anti-Xa units s.c. daily versus placebo s.c. daily. The primary outcome is VTE-free survival at 6 months. Progression free survival; overall survival, toxicity, and neurocognitive performance are secondary outcome measures.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Kellogg Cancer Center - Evanston Northwestern Healthcare, Evanston, Illinois, United States
Henry Ford Hospital, Detroit, Michigan, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
The St. George Hospital, Kogarah, New South Wales, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Cross Cancer Institute, Edmonton, Alberta, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
The Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
Toronto-Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Ospedali Riuniti di Bergamo, Bergamo, , Italy
Università di Perugia, Perugia, , Italy
Contact Details
Name: James Perry, MD
Affiliation: Toronto Sunnybrook Regional Cancer Centre
Role: STUDY_CHAIR
Name: Mark Levine, MD
Affiliation: Ontario Clinical Oncology Group (OCOG)
Role: PRINCIPAL_INVESTIGATOR
Name: William Geerts, MD
Affiliation: Toronto Sunnybrook Regional Cancer Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Jim Julian, MMath
Affiliation: McMaster University, Dept of Clinical Epidemiology & Biostatistics
Role: PRINCIPAL_INVESTIGATOR
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